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The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and/or continuous monitoring of patients during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The subject device is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation (SpO₂). It is also equipped with an audio/video camera to monitor the patient in real time. In addition, the subject device provides visual and auditory alarms that alert the caregiver when a patient's pulse rate and/or SpO2 falls outside of preset limits or when a technical error is detected. During a physiological alarm event, the pulse rate and SpO2 data along with the audio/video data are recorded automatically by the subject device. The careqiver can review the historical data whenever needed.

The system consists of a self-contained wrist-worn Sensor Module (SM), a Receiver/ Transponder (RT) with an embedded audio/video camera and a portable, table-top wireless Display Unit (DU).

It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements are taken by the SM and are transmitted to the RT which delivers the measurements along with audio/video signals to the DU for display, wherein Bluetooth technology is used to transmit data between the SM and the RT, and data is transmitted from the RT to the DU via the Wi-Fi 802.11 band.

The provided text describes the acceptance criteria and a study for the Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, which measures functional oxygen saturation (SpO2) and pulse rate.

Here's an organized breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device's accuracy was verified through a clinical study. The acceptance criterion for SpO2 accuracy is explicitly mentioned in relation to the FDA guidance.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: "healthy adult subjects" (number not specified, but stated "Over 200 data points were collected").
• Data Provenance: The study involved "healthy adult subjects" and used "controlled induced hypoxia." The country of origin for the data is not specified within the provided text. It is a prospective study as it involved collecting new data on subjects under controlled conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

The document does not mention the use of experts or their qualifications for establishing ground truth in this context. For pulse oximetry accuracy studies, the "ground truth" (reference measurement of arterial oxygen saturation, SaO2) is typically established through co-oximetry of arterial blood samples, not expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth for pulse oximetry accuracy is derived from direct physiological measurements (co-oximetry), not subjective expert judgment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted. This device is a vital sign monitor, and its performance is evaluated based on the accuracy of its physiological measurements against a reference standard, not human interpretation of images or other data. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this type of device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, the clinical study directly assesses the standalone performance of the device (the oximeter) in measuring SpO2 and pulse rate against a reference standard, without human interpretation of the device's output to determine diagnosis. The Ams value reported represents the algorithm's performance.

7. Type of Ground Truth Used:

The ground truth used was established via physiological measurements during controlled induced hypoxia. While not explicitly detailed in this excerpt, for pulse oximeters, the gold standard for SpO2 "ground truth" is typically fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples.

8. Sample Size for the Training Set:

The provided text does not specify a training set size. This type of device (an oximeter) typically relies on established physiological principles and signal processing algorithms derived from extensive research and development in pulse oximetry, rather than a "training set" in the machine learning sense for a new AI algorithm. While there's internal algorithm development, the document refers to a clinical study for verification of accuracy, not for training a model.

9. How the Ground Truth for the Training Set Was Established:

As no explicit training set is mentioned in the context of a machine learning model, this question is not fully applicable based on the provided text. The device's underlying technology and ground truth for its development would be based on the established physiological relationship between light absorption and oxygen saturation, validated through extensive physiological studies over decades of pulse oximetry development.

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The ViSI Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (TEMP), posture tracking and basic arthythmia (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation) analysis and alarm in hospital-based facilities including general medical-surgical floors, intermediate care floors, and emergency departments.

Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation. The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older; it has not been evaluated on pediatric patients.

The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.

The Visl Mobile Insight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSI Mobile patient-worn device.

The ViSi Mobile Monitoring System is a patient worn, portable, battery operated, continuous physiological monitoring device intended for the monitoring of ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (SKIN TEMP), posture tracking and alarms, basic arrhythmia analysis (ventricular fibrillation, ventricular tachycardia, asystole, atrial fibrillation) and alarms.

The ViSi Mobile Monitoring System consists of the patient worn devices, disposables, backup battery, patient data server and remote viewer.

This document (K180472) is a 510(k) premarket notification for the ViSi Mobile Monitoring System. The focus of the provided text is to demonstrate substantial equivalence to a predicate device, primarily by highlighting changes and comparing technical characteristics and performance, especially concerning arrhythmia detection.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" in the traditional sense for the acceptance of the device as a whole. Instead, it presents performance metrics against recognized standards (ANSI/AAMI EC57: 2012) for its arrhythmia detection algorithm, comparing the improved "Proposed Device" (Subject Device) with a "Reference Device A" (K142827), which is a previously cleared version of the ViSi Mobile Monitoring System.

Here's a table derived from the provided "C. Atrial Fibrillation Comparison" and "E. ALARM TEST COMPARISON" sections, focusing on the arrhythmia detection performance:

The study that proves the device meets the acceptance criteria is primarily non-clinical, using established databases.

2. Sample size used for the test set and the data provenance

The test set utilizes publicly available, established databases:

• AHA (American Heart Association)
• MIT-BIH (Massachusetts Institute of Technology - Beth Israel Hospital Arrhythmia Database)
• CU (Creighton University Ventricular Tachyarrhythmia Database)
• NST

The specific sample sizes (e.g., number of ECG recordings or patients) from these databases are not explicitly stated in the provided text. The provenance is from these known databases, which are widely accepted for arrhythmia algorithm testing. The data within these databases is retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states: "The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282), which has been adapted for real time analysis in the ViSi System. The ViSi Monitoring System arrhythmia analysis has been validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012."

The ground truth for these databases (AHA, MIT-BIH, CU, NST) was established by experts, typically cardiologists or electrophysiologists, during the creation of the databases. The specific number and qualifications of these experts are not detailed within this 510(k) document but are inherent to the accepted nature of these standard databases.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set data itself. The ground truth for the test sets (AHA, MIT-BIH, CU, NST databases) was established independently by the creators of those databases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. A multi-reader multi-case (MRMC) comparative effectiveness study involving human readers is not described in this document. The study focuses purely on the algorithm's performance against established gold-standard databases, comparing an updated algorithm to a previous version and recognized standards. The device is not presented as an AI-assistance tool for human readers but rather as a standalone monitoring system with an integrated arrhythmia detection algorithm.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes. The performance evaluation presented is a standalone (algorithm only) performance assessment. The tables show the algorithm's sensitivity and positive predictivity for various arrhythmia events (VF/VT, AFIB) when processing the specified ECG databases. The context further reinforces this, stating "Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention," indicating it acts as an aid rather than requiring human modification of its output for the test.

7. The type of ground truth used

The ground truth used for the performance testing is expert consensus from established, recognized ECG databases (AHA, MIT-BIH, CU, NST). These databases contain expert-annotated ECG waveforms, which serve as the gold standard for evaluating arrhythmia detection algorithms.

8. The sample size for the training set

The document does not explicitly state the sample size of the training set used to develop or refine the arrhythmia detection algorithm. It mentions that "The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282)," which implies that the training might have occurred prior to this submission (or the core technology was pre-trained).

9. How the ground truth for the training set was established

The document does not explicitly detail how the ground truth for the training set was established. Given that the algorithm is based on (or an adaptation of) the Monebo Technologies, Inc Arrhythmia library, it's highly probable that the training also utilized similar expert-annotated ECG datasets or proprietary clinical data. The document does state that the arrhythmia algorithm was "Rewritten to improve specificity and detection metrics" and later "New arrhythmia detection algorithm to improve arrhythmia detection accuracy and positive predictivity," implying development and testing that would have involved ground truth data.

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